Covidien receives U.S. FDA 510(k) clearance for reinforced stapling technology

Covidien's Endo GIA Reinforced Reload stapler--Courtesy of Covidien

Covidien ($COV) won the FDA's 510(k) clearance for a high-tech surgical stapling technology, adding another product to its growing portfolio.

The clearance marks a second big win for Covidien, as its Tri-Staple technology was recently approved in Japan. The company plans to release the device in the Japanese and U.S. markets during the coming months.

Endo GIA Reinforced Reload with Tri-Staple technology contains advanced felt material that allows physicians to provide additional support when delivering surgical staples. The device will help eliminate extra steps during operations and reduce procedure times, said Covidien's chief medical officer Michael Tarnoff in a statement.

The news comes in the midst of company change: In January, Covidien abandoned its renal denervation program due to slow market growth and set its sights on R&D and emerging markets. The Dublin-based company recently won FDA clearance for its LigaSure laparoscopic device, and acquired manufacturers in Brazil and China. In December, Covidien signed an $860 million deal with Given Imaging ($GIVN)--the maker of the popular PillCam endoscopic device.

For the moment, it looks like the company's efforts have begun to pay off. Covidien posted a slight boost in sales last quarter, and increased its net revenue by 3% to $2.6 billion--partly due to a 6% rise in its leading surgical solutions business. New technology and investment in R&D could be just what it needs to pull itself out of a sales slump--and increase revenue during the coming year.

- read the release

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